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eCTD Templates

eCTD templates

The challenge

Submitting electronically requires accuracy in content as well as format. File naming and formats are defined and will be checked during technical validation, a process used by the agencies to establish whether an eCTD or NeeS submission is in line with latest regulations. This will include for example the type of font used, the Portable Document Format (PDF) version or whether a document opens in Fast Web View.

Documents themselves are usually coming from different sources during the dossier compilation process and checks should be made to ensure compliance to latest regulations.

The solution

Samarind RMS contains a set of predefined templates that support our users during the document creation process. Compliant fonts have been used together with additional MS Word ® “styles” making it easy for authors to concentrate on content rather than format. Our templates allow the creation of bookmarks to aid navigation and can be setup with “attributes” to follow the Emerging Dossier Concept. By using “attribute” information is collected from the central repository and inserted into the documents during the creation process, ensuring information consistency throughout.

The benefits

Creating documents using Samarind’s eCTD templates has many advantages.

  • Creating eCTD-ready documents from day one, minimising later rework and corrections, saving time and effort when it matters most
  • Information reuse via “attributes” that are automatically filled during document creation from the repository, following the Emerging Dossier Concept
  • Assisting authors with content creation via regulatory guidance
  • The use of MS Word ® styles to allow automated PDF bookmark creation
  • Correct use of fonts and margins that follow latest guidance.

Using Samarind’s templates to create the final PDF rendition could not be easier as all technical aspects are taken care of.

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